• Experience is what you get right after you need it.

    Let us bring you our experience.

The Perfect Solution For You! So, what are you waiting for?

BGF Consultants are trained to provide you with A to Z compliance solutions
Call Us Now!
%regulatory compliance%regulatory compliance consulting
 

REGULATORY AFFAIRS SOLUTIONS

  • PREPARATION AND REVIEW OF REGULATORY FILINGS
  • REGULATORY INTERACTION
  • PHARMACOVIGILANCE ACTIVITIES
  • DEVELOPMENT OF REGULATORY STRATEGY
  • LABELING AND PROMOTIONAL MATERIAL REVIEW
  • REGULATORY GAP ASSESSMENT OF DRUG, MEDICAL DEVICE, AND BIOLOGIC PRODUCTS AND PROCESSES
  • MANUFACTURING PROCESS EVALUATION AND OPTIMIZATION
  • SCREENING AND OVERSIGHT OF CTOS AND CMOS

Regulatory Training Solutions

  • GOOD MANUFACTURING PRACTICES (GMP) TRAINING
  • INSPECTION READINESS
  • AUDITING
  • VALIDATION
  • BATCH RECORD REVIEW & RELEASE
  • CORRECTIVE AND PREVENTATIVE ACTION (CAPA)
  • DEVIATION MANAGEMENT & ROOT CAUSE ANALYSIS
  • PRESCRIPTION DRUG MARKETING ACT (PDMA) & SAMPLING HANDLING
  • ASEPTIC GOWNING AND BEHAVIOR

AUDITING SOLUTIONS

  • COMPLIANCE GAP ANALYSIS AND REMEDIATION PLANS
  • INSPECTION READINESS
  • SUPPLIER AUDITING
  • SERVICE PROVIDER AUDITING
  • INTERNAL AUDITING

Validation Services

  • VALIDATION MASTER PLAN
  • CLEANING VALIDATION PROGRAM
  • EQUIPMENT VALIDATION
  • PROCESS VALIDATION
  • FACILITY AND UTILITY QUALIFICATION

Download our Regulatory Affairs Consulting Brochure below!


Your Name (required)

Your Email (required)